Computer Stop Order Alert to Prevent Concurrent Prescribing of Trimethoprim/Sulfamethoxazole and Warfarin (warf-tmp/smx)

This study has been terminated.

(four adverse events encountered)

Sponsor:

Information provided by:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT00870298

First received: March 26, 2009

Last updated: NA

Last verified: March 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	March 26, 2009
Last Updated Date	March 26, 2009
Start Date ^ICMJE	August 2006
Estimated Primary Completion Date	January 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 26, 2009)	Reduce concomitant orders for warfarin and tmp/smx [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: March 26, 2009)	Determine if computerized stop order will increase risk for inadvertent cessation of warfarin [ Time Frame: 7 months ] [ Designated as safety issue: Yes ] Determine if computerized stop order will increase risk of delay of treatment with tmp/sulfa when determined to be necessary for treatment [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Computer Stop Order Alert to Prevent Concurrent Prescribing of Trimethoprim/Sulfamethoxazole and Warfarin
Official Title ^ICMJE	Randomized Controlled Study of a Computer Stop Order Versus Routine Practice When Trimethoprim/Sulfamethoxazole is Ordered Concurrently With Warfarin
Brief Summary	To determine if a computerized stop order will reduce the number of concurrent trimethoprim/sulfamethoxazole and warfarin orders accepted through the inpatient electronic ordering system while a patient is hospitalized.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Condition ^ICMJE	Prescribers' Drug Orders
Intervention ^ICMJE	Drug: Trimethoprim/Sulfamethoxazole and Warfarin
Study Arm (s)	Experimental: computerized alert An automatic electronic stop of the tmp/sulfa or warfarin order whenever a resident or nurse practitioner places an order for tmp/sulfa with an already active warfarin order, or when ordering both simultaneously Intervention: Drug: Trimethoprim/Sulfamethoxazole and Warfarin 2 Current practice Current practice of the pharmacist recommending cessation of concurrent warfarin and tmp/sulfa orders Intervention: Drug: Trimethoprim/Sulfamethoxazole and Warfarin
Publications *	Strom BL, Schinnar R, Aberra F, Bilker W, Hennessy S, Leonard CE, Pifer E. Unintended effects of a computerized physician order entry nearly hard-stop alert to prevent a drug interaction: a randomized controlled trial. Arch Intern Med. 2010 Sep 27;170(17):1578-83.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	1971
Completion Date	January 2007
Estimated Primary Completion Date	January 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: All resident physicians and nurse practitioners involved in inpatient care. Exclusion Criteria: None-
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00870298
Other Study ID Numbers ^ICMJE	803788
Has Data Monitoring Committee	No
Responsible Party	Brian L. Strom, MD, MPH, UPenn
Study Sponsor ^ICMJE	University of Pennsylvania
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Pennsylvania
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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